Catalog Number

-

Brand Name

Safe Warrior

Version/Model Number

MSK1001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 25, 2020

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

7b918bf9-123d-4d9c-aa6e-7313ae429d88

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

March 25, 2020

Package DI Number

00810014760810

Quantity per Package

110

Contains DI Package

00810014760605

Package Discontinue Date

March 25, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE